double antibiotic

Generic: bacitracin zinc and polymyxin b sulfate

Labeler: stratus pharmaceuticals inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name double antibiotic
Generic Name bacitracin zinc and polymyxin b sulfate
Labeler stratus pharmaceuticals inc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 500 [USP'U]/g, polymyxin b sulfate 10000 [USP'U]/g

Manufacturer
STRATUS PHARMACEUTICALS INC

Identifiers & Regulatory

Product NDC 58980-012
Product ID 58980-012_6c82f396-e1f6-4210-87b1-2615eedbdc6a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2027-12-31
Marketing Start 2017-09-15

Pharmacologic Class

Classes
decreased cell wall synthesis & repair [pe] polymyxin-class antibacterial [epc] polymyxins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58980012
Hyphenated Format 58980-012

Supplemental Identifiers

RxCUI
308512
UNII
89Y4M234ES 19371312D4

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name double antibiotic (source: ndc)
Generic Name bacitracin zinc and polymyxin b sulfate (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 500 [USP'U]/g
  • 10000 [USP'U]/g
source: ndc
Packaging
  • 144 PACKET in 1 BOX (58980-012-01) / .9 g in 1 PACKET
  • 1 TUBE in 1 BOX (58980-012-05) / 14.2 g in 1 TUBE
  • 1 TUBE in 1 BOX (58980-012-10) / 28.35 g in 1 TUBE
source: ndc

Packages (3)

58980-012-01 144 PACKET in 1 BOX (58980-012-01) / .9 g in 1 PACKET 58980-012-05 1 TUBE in 1 BOX (58980-012-05) / 14.2 g in 1 TUBE 58980-012-10 1 TUBE in 1 BOX (58980-012-10) / 28.35 g in 1 TUBE

Ingredients (2)

bacitracin zinc (500 [USP'U]/g) polymyxin b sulfate (10000 [USP'U]/g)

Linked Drug Pages (1)

BACITRACIN ZINC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "6c82f396-e1f6-4210-87b1-2615eedbdc6a", "openfda": {"unii": ["89Y4M234ES", "19371312D4"], "rxcui": ["308512"], "spl_set_id": ["f64b3564-ea3c-4316-8f00-f92c08dcad35"], "manufacturer_name": ["STRATUS PHARMACEUTICALS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "144 PACKET in 1 BOX (58980-012-01)  / .9 g in 1 PACKET", "package_ndc": "58980-012-01", "marketing_start_date": "20170915"}, {"sample": false, "description": "1 TUBE in 1 BOX (58980-012-05)  / 14.2 g in 1 TUBE", "package_ndc": "58980-012-05", "marketing_start_date": "20210208"}, {"sample": false, "description": "1 TUBE in 1 BOX (58980-012-10)  / 28.35 g in 1 TUBE", "package_ndc": "58980-012-10", "marketing_start_date": "20260126"}], "brand_name": "Double Antibiotic", "product_id": "58980-012_6c82f396-e1f6-4210-87b1-2615eedbdc6a", "dosage_form": "OINTMENT", "pharm_class": ["Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "58980-012", "generic_name": "BACITRACIN ZINC and POLYMYXIN B SULFATE", "labeler_name": "STRATUS PHARMACEUTICALS INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Double Antibiotic", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "500 [USP'U]/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170915", "listing_expiration_date": "20271231"}